Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

Background
Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD.
Methods and Findings
In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control.
Conclusions
An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention.
Trial Registration
Controlled-Trials.com ISRCTN45433299

研究背景
传统基层医疗场景中，自我管理支持的落地实践已被证实存在诸多挑战，这推动了与社区资源主动联动的替代照护模式的研发。慢性肾脏病（Chronic Kidney Disease, CKD）是一类常见病症，通常在合并其他共病时被确诊。本试验旨在评估针对3期慢性肾脏病患者，提供信息咨询及电话引导式社区支持接入的干预方案相较于常规照护的有效性。

研究方法与结果
本研究为务实型、双组、患者水平随机对照试验，从大曼彻斯特地区的24家全科诊所招募了436名确诊为3期慢性肾脏病的患者。患者被随机分配至干预组（215例）与常规照护组（221例）。本研究的主要结局指标为随访6个月时的健康相关生活质量（EQ-5D健康问卷，EQ-5D health questionnaire）、血压控制情况，以及生活积极参与度（heiQ）。
随访6个月时，干预组的平均健康相关生活质量显著高于对照组（校正后均数差=0.05；95%置信区间[CI]=0.01, 0.08）；干预组血压控制达标患者的占比也显著更高（校正后比值比=1.85；95%置信区间[CI]=1.25, 2.72）。两组在生活积极参与度方面无显著差异。干预组的医疗成本相较于对照组有所降低。

研究结论
相较于常规照护，针对3期慢性肾脏病患者提供定制化信息咨询及电话引导式社区资源接入的干预方案，可小幅但显著改善患者的健康相关生活质量，并更好地维持血压控制水平。不过，仍需开展进一步研究以阐明该干预方案的作用机制。

试验注册
Controlled-Trials.com ISRCTN45433299